D-0277-2024 Class I Ongoing
FDA drug recall D-0277-2024 was initiated by Denver Solutions, LLC DBA Leiters Health on December 28, 2023 and is designated Class I. Reason for recall: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. The recall status is ongoing. Affected quantity: 8,976 IV bags.
Recall Details
- Product Type
- Drugs
- Report Date
- February 7, 2024
- Initiation Date
- December 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,976 IV bags
Product Description
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
Reason for Recall
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 2331062, Exp. Date: 02/08/2024; 2331224, Exp. Date 03/18/2024; 2331270, Exp. Date 03/28/2024.